Laparoscopic tool and method

ABSTRACT

The present invention is directed to an apparatus for use in internal surgical procedures and is particularly advantageous for use in laparoscopic surgical procedures. An example implementation is directed to a tool having a depth-adjustable cannula having an upper portion that rests on the body, and having an automatically-sealing channel that readily accepts the insertion and removal of surgical instruments without permitting gases to pass. In one particular embodiment, the tool includes a low-profile platform for stabilizing the tool on a body layer, a projection channel with a flexible sleeve for maintaining the channel closed, and an adjustable member for setting the penetration depth of the tool. The flexible sleeve is sufficiently elastic to close the inner channel in response to pressurization between the outside of the flexible sleeve and the inner surface of the hollow channel. The low-profile platform and the adjustable member permit use of the same tool for different body-wall thicknesses.

RELATED PATENT DOCUMENTS

[0001] This is a continuation application of U.S. patent applicationSer. No. 09/246,228, filed on Feb. 8, 1999 (PHIL.110PA), which isrelated to U.S. patent application entitled, “Choker-Catheter,” Ser. No.08/988,157, filed on Dec. 12, 1997 (now U.S. Pat. No. 6,004,303), andassigned to the instant assignee and incorporated herein in itsentirety, to which priority is claimed.

FIELD OF THE INVENTION

[0002] The present invention relates to an apparatus for use inlaparoscopic surgery and, more particularly, to an apparatus forproviding a seal or valve structure within a cannula which effectivelyand cost efficiently prevents inert gas from escaping while allowing therepeated insertion and removal of surgical instruments through thecannula.

BACKGROUND OF THE INVENTION

[0003] Recent advancements in surgical techniques and instruments havepermitted for incisions of reduced size for a variety of surgicalprocedures. For example, surgical procedures which only a few years agorequired an incision six or seven inches in length are today performedthrough incisions requiring less than one inch in length. Among otheradvancements, one type of surgical instrument that has been significantin this regard is the trocar.

[0004] In general, a trocar is a sharply pointed surgical tool that isused to create and maintain small, bowl-like incisions in a body cavity.Surgical instruments, including miniaturized optical devices, can beinserted through these small incisions and manipulated to performsurgical procedures within the body cavity without ever exposing thepatient's internal organs or structures to the outside environment. Byenabling the creation and maintenance of small working holes within apatient's body wall, conventional trocars have greatly contributed tothe reduction and size of the incisions required to perform surgicalprocedures thereby reducing the related complications.

[0005] Conventional trocars generally include an obturator and acannula. An obturator is a small, nail-like structure for penetratingthe body wall to create a working channel into the body cavity. Thecannula is a tube-like structure which is inserted into the incisionmade by the obturator to maintain a working channel even after theobturator is removed. In a typical scenario, the obturator and cannulaare assembled into a single unit by inserting the obturator within thecannula, and then a combination is used to puncture the body wall. Theobturator can then be carefully withdrawn from the cannula withoutremoving the cannula from the body wall. Surgical instruments can beinserted through this cannula to perform an entire surgical procedurewithin the body cavity.

[0006] In many surgical procedures involving trocars, the body cavity isinflated with a nontoxic gas before the trocar is employed to create aworking pocket or volume within the patient and to prevent the trocarfrom penetrating internal organs during insertion. In an appendectomyprocedure, for example, a patient's abdomen is inflated with a gasthrough a veress needle. The obturator is then used to place cannulas invarious locations throughout the inflated abdomen to perform theprocedure. One such cannula would typically be used to pass a smallcamera and light into the body cavity so the surgeon could view theoperating area within the patient. Other cannulas would be used at otherlocations to pass surgical instruments into the cavity and remove tissuesuch as the appendix from the patient.

[0007] Maintaining the patient's abdomen in an inflated state throughoutthis procedure is important. To this end, cannulas are often providedwith sealing flap valves that are arranged to prevent gas from escapingfrom the patient's abdomen after the obturator has been withdrawn. Thesesealing valves, however, do not prevent gas leakage when the surgicalinstrument has a diameter that is smaller than the diameter of thecannula seal. Instead gas can easily pass through the gap between theinner walls of the cannula and the outer surface of the surgicalinstrument to deflate the work area. To prevent such deflation of thistype from occurring, physicians often are required to utilize only thoseinstruments whose dimensions closely match those of the cannula. Thisrequirement apparently limits the surgeon's freedom of choice inselecting surgical instruments for the procedure. Thus, while asurgeon's instrument might be preferred by a physician, the physicianmight nonetheless be forced to use a less preferred, and possibly lesseffective, tool to perform a procedure to avoid deflating a body cavity.

[0008] It is also important for the surgeon to use an assembledobturator and cannula for the particular operation and/or patient.Depending on the body cavity to be explored and the patient undergoingthe surgery, the surgical procedures can vary significantly. Forexample, using an assembled obturator and cannula to puncture thestomach of a baby is quite different than using an assembled obturatorand cannula to puncture the stomach of an obese adult. Typically, theprocedure for a baby requires that the assembled obturator and cannulabe inserted just a short way, enough to pierce a thin stomach wall.Conversely, the same procedure for an obese adult requires that theassembled obturator and cannula be inserted through a relatively thickstomach wall. For such procedures, the conventional obturator andcannula assembly is often too long or too short, thereby making thesurgery awkward. For example, when using an obturator and cannulaassembly that is too long, the upper end of the assembly extends farabove the stomach wall thereby making the assembly unstable.

[0009] Accordingly, there is a need for a surgical instrument andprocedure that addresses the above-mentioned, and other, problems in theprior art.

SUMMARY OF THE INVENTION

[0010] The present invention is directed to an apparatus or tool for usein internal surgical procedures and, more particularly, to alaparoscopic tool for surgical procedures. In a more specific exampleembodiment, the tool includes a low-profile platform for stabilizing thetool on a body layer, a collapsing sleeve in a projection channel withinthe tool for maintaining the channel closed, and an adjustable memberfor setting the penetration depth of the tool.

[0011] In another example embodiment, an apparatus is used for insertingthrough a body layer and into a body cavity for surgical procedures. Theapparatus includes: an elongated tube including an entry port, a channeland an extended portion configured and arranged to extend the entry portabove the body layer; and a flexible sleeve located within the hollowchannel of the tube and being supported via the elongated tube at firstand second locations of the elongated tube, wherein the flexible sleeveis configured and arranged to have slack between the first and secondlocations such that the sleeve is compressed when under pressure whilein use to close the opening.

[0012] In another particular embodiment, a method for accessing througha body layer and into a body cavity for surgical procedures, comprises:providing a tool including an entry port, a channel and an extendedportion configured and arranged to extend the entry port above the bodylayer, and providing a flexible sleeve within the hollow channel;inserting the tool into the body and setting the extended portion on thebody layer; placing an instrument within the channel and within theflexible sleeve; permitting the flexible sleeve to conform around theinstrument while the instrument is within the channel, and permittingthe flexible sleeve to close upon itself while no object is within thechannel, such that the flexible sleeve includes sufficient slack betweenthe first and second locations that the sleeve responds as such whenunder pressure.

[0013] Another example implementation is directed to a tool having adepth-adjustable cannula having an upper portion that rests on the body,and having an automatically-sealing channel that readily accepts theinsertion and removal of surgical instruments without permitting gasesto pass through a channel in the cannula.

[0014] The above summary of the present invention is not intended todescribe each illustrated embodiment of the present invention. Otheraspects and embodiments of the invention will become apparent upon areview of the figures and detailed description.

BRIEF DESCRIPTION OF THE DRAWINGS

[0015] The invention may be more completely understood in considerationof the detailed description of various embodiments of the inventionwhich follow in connection with the accompanying drawings, in which:

[0016]FIG. 1A is a perspective view of an example surgical tool,according to the present invention, with a body-piercing portion of thetool removed;

[0017]FIG. 1B is a perspective view of the body-piercing portion of theexample surgical tool of FIG. 1A, according to the present invention;

[0018]FIG. 1C is a cross-sectional side-end view of the example surgicaltool of FIGS. 1A and 1B, according to the present invention, shown inassembled form;

[0019]FIG. 1D is a perspective view of the example surgical tool ofFIGS. 1A and 1B, according to the present invention, shown in assembledform;

[0020]FIG. 1E is a perspective view of the example surgical tool of FIG.1A, according to the present invention, shown in unassembled form;

[0021] FIGS. 2A-2F are perspective views of various portions of anexample surgical tool manufactured in a manner consistent with theexample surgical tool of FIGS. 1A, 1B and 1C, also according to thepresent invention;

[0022]FIG. 3A is a side view of an outer cannula and an inner seal of anexample surgical tool according to the present invention;

[0023]FIG. 3B is an end view according to the present invention of thecannula with its inner seal of the example surgical tool of FIG. 3A; and

[0024]FIG. 3C is a perspective view showing how a surgical instrument,such as illustrated in FIGS. 3A and 3b, can be inserted through thecannula and its inner seal while maintaining a closed seal within thecannula, also according to the present invention.

[0025] While the invention is amenable to other various modifications inalternative forms, specifics thereof have been shown by way of examplein the drawings and will be described in detail. It should beunderstood, however, that the intention is not to limit the invention toa particular embodiment described. On the contrary, the intention is tocover all modifications, equivalents, and alternatives falling withinthe spirit and scope of the invention as defined by the appended claims.

DETAILED DESCRIPTION

[0026] The present invention is applicable to a variety of apparatus andarrangements in which external instruments are to be passed through anopening separating two environments in which a pressure differencebetween these environments exists and in which maintaining a sealbetween these environments is beneficial. The invention has been foundto be particularly advantageous in laparoscopic surgery where surgicalinstruments are passed into a body cavity (human or otherwise) toperform an operation. While the present invention is not so necessarilylimited, various aspects of the invention can be appreciated throughdiscussion of application examples in such an environment.

[0027] Turning now to the drawings, FIGS. 1A-1E illustrate an examplelaparoscopic tool 100 that is used to create and maintain a smallincision through a body layer, such as a stomach wall, having any of anumber of thicknesses. FIG. 1A shows the tool 100 from a side view withthe piercing portion of the tool 100 removed. The laparoscopic tool 100includes a main body 112 including an upper portion 112 a and anelongated section 112 b having a hollow center channel, an innerflexible tube 115 for collapsing the channel sealed, and an outeradjustment sleeve 116 adapted to provide a depth-settable scope at thebottom of the tool 100. The inner flexible tube 115 is open-ended ateach end and fits within the channel of the elongated section 112 b. Theinner flexible tube 115 has one end secured between a tube lock 132 andthe upper portion 112 a, and has another end secured at a location 123near the end of the elongated section 112 b, for example, using a heatweld, glue or other adhering substance. The inner flexible tube 115 hassufficient slack so that it collapses closed under a pressure in thebody cavity, for example, as provided into the body cavity via a gassupply feeding a channel 120.

[0028]FIG. 1B shows the piercing portion of the tool 100 of FIG. 1A.This portion of the tool 100 includes a pin 114 secured at an upper endto a pin holder 130, and a lock 118. The lock 118 has a lock head 118 a,a pin-receiving channel 118 b, and a separable end 118 c. The separableend 118 c includes a plurality of sections (e.g., 3 or 4), each havingan outwardly-extending protrusion 118 d that is designed to lock into acorresponding aperture 116 a within the outer adjustment sleeve 116 ofFIG. 1A.

[0029] As shown in the cross-sectional view of FIG. 1C, the piercingportion (FIG. 1B) of the tool 100 is inserted into the inner flexibletube 115 within the channel of the elongated section 112 b. Onceassembled, the piercing portion (FIG. 1B) of the tool 100 can beadjusted along the elongated section 112 b so that the distance betweenthe underside of the upper portion 112 a and the girth at the bottom ofthe pin 114 corresponds to the thickness of the body layer beingpenetrated. With the piercing portion of the tool 100 adjusted for thecorresponding body layer thickness, the upper portion 112 a can rest onthe body layer and thereby provide a foundation above the fatty bodylayer for insertion and control of instruments to be inserted through(into and out of) the inner flexible tube 115. The entry port, beginningat the upper side of the upper portion 132 a, has a conical shape to aidin guiding instruments into the inner flexible tube 115.

[0030] The above example embodiment of the present invention isadvantageous in that only one laparoscopic tool is needed for a varietyof body layer thicknesses. The above embodiment is also advantageous inthat the upper portion 112 a of the main body 112 extends above the bodylayer. This provides the operator (or surgeon) a wide and elevated base,or platform, over the outer body layer and from which the operator cancontrol the surgical instruments. In one embodiment, the upper portion112 a is about ¾ inch high and several inches wide; however, the heightand girth of the upper portion 112 a can vary.

[0031]FIGS. 1D and 1E respectively illustrate perspective views of thetool 100 of FIG. 1A in assembled and unassembled form.

[0032] Referring now to FIGS. 1C-1D, the pin holder 130 includes acurved surface that mates with a curved surface on the lock head 118 a.When the pin holder 130 is turned relative to the lock head 118 a sothat the two surfaces are in a locked and non-mated position, thesecurved surfaces provide a cam action to draw the bulb end of the pin 114part way into the end of the lock 118. This cam action, in turn, causesthe flexible end 118 c of the lock 118 to lock into the end 116 a of thesleeve 116, thereby setting the various parts of the laparoscopic tool100 so that it can be used to make the desired incision. Once theincision is made, the gas supply can be used to inflate the innerflexible tube 115 and body cavity, and the pin holder 130 can be turnedrelative to the lock head 118 a so that the two surfaces are in a matedposition. Turning the pin holder 130 in this manner causes the flexibleend 118 c of the lock 118 to be released from its lock into the end 126a of the sleeve 116. The lock head 118 a is then drawn upward and out ofthe main body 112 to remove the lock 118 and the pin/pin-holder assembly114/130 from the main body 112. Surgical instruments are then insertedinto the tube lock 132 and the end of the inner flexible tube 115 forviewing and/or surgical manipulations within the inflated cavity.

[0033] Another important aspect of the present invention concernsmaintaining that the body cavity is in an inflated state throughout theprocedure. To this end, the inner flexible tube 115 is configured andarranged to seal the incision during the surgery, even after the pin 114is withdrawn and other instruments are inserted and withdrawn.Regardless of the diameters of the instruments, gas cannot easily passinto or out of the body cavity and deflate the work area. In variousembodiments, the inner flexible tube 115 is constructed of a slipperypolyurethane or Teflon-like material to permit the easy passage of anexternal instrument through the sleeve to exit the rigid tube 102 at itsfirst end 106. The slippery, plastic, polyurethane-like material alsoprovides the required elasticity to allow the flexible tube to becompressed under pressure to close the opening of the inner channelformed within the flexible tube.

[0034] When used for laparoscopic surgery, the tool 100 creates a smallhole within the body cavity, with the hole sized to match the outerdiameter of the outer adjustment sleeve 116. The body cavity isgenerally pressurized using an inert gas, such as CO₂, such that theinternal pressure within the body cavity is greater than the outsideair. When the outer adjustment sleeve 116 is inserted within thepressurized body cavity, this pressurization enters the outer adjustmentsleeve 116 at its lower end and thereby compresses the inner flexibletube 115. Because the flexible tube 115 is attached at the end of themain body 112, the flexible tube 115 gathers and compresses, closing thechannel along the whole length of the flexible tube 115 and preventingthe escape of the pressurized gas from inside the body cavity.

[0035] When in this configuration, a surgical instrument can be insertedthrough tube lock 132 to enter within the inner channel of the nowcollapsed inner flexible tube 115. As the instrument is inserted throughthe flexible tube, the flexible tube will conform around the externalinstrument, thus permitting the instrument to pass through the innerflexible tube 115 and exit the rigid main body 112. At the same time,the pressurization is present within the main body's upper end. Thepressurization continues to press the flexible tube against the surfacesof the external instrument as it passes through the inner channel. Theexternal instrument can now be used to perform surgical procedureswithin the body cavity.

[0036] As the external instrument is removed, it passes back through theinner channel of the flexible tube. Pressurization from within the bodycavity maintains the collapsed structure of the flexible tube, therebymaintaining the seal of the inner channel around the instrument until itis closed when the instrument is completely removed.

[0037] In accordance with one aspect of the present invention, anexample surgical procedure includes using the laparoscopic tool 100 inassembled form (FIG. 1B) to puncture an incision through a body wall.This procedure includes setting the outer adjustment sleeve 116 so thatit is ratched all the way up along the elongated section 112 b towardthe upper portion 112 a. In one implementation, the outer adjustmentsleeve 116 sleeve includes an encircling ridge 116 b for catching andlocking onto the protrusions 112 c of the elongated section 112 b. Thepuncture is then performed by pressing the tool 100 into the body untilthe underside of the upper portion 112 a resides on the skin or outerbody layer. In one example application, the underside of the upperportion 112 a is adhered to the stomach wall using two-way tape 108.Next, with the main body 112 held against the skin, the lock 118 ispressed downward. This causes the outer adjustment sleeve 116 to ratchetwith the pin further into the body cavity, then to the desired depth. Inone application, the position of the outer adjustment sleeve 116 isselected for a desired depth (e.g., up to 3-4½ inches below the mainbody 112), depending on the thickness of the body layer (e.g., body fat)from the outer skin or layer to where the incision reaches the bodycavity. Once the incision is complete, the pin 114 and the lock 118 areunlocked and removed to permit a surgical instrument to be inserted intothe inflated body area for viewing and manipulation.

[0038] FIGS. 2A-2F show perspective views of example parts used forimplementing the surgical tool 100 of FIGS. 1A, 1B and 1C. In FIG. 2A,the upper portion 112 a of the main body 112 is shown to include arecess area for receiving and securing therein an end of the flexibletube (115 of FIG. 1A) with the tube lock (132 of FIG. 2F) over the endof the flexible tube.

[0039] The main body 112 further includes protrusions 112 c along itsextended portion for engaging and locking to an encircling ridge 116 bon the inner surface of the sleeve 116 (FIG. 2D). According toalternative example embodiments consistent with the present invention,the adjustment mechanism providing this engaging and locking can beimplemented using the illustrated ratchet-like ladder along the lengthof the extended portion of the main body 112. Alternative lockingmethods include threads or an elongated tube. By using a nonpermanentsecuring mechanism such as the illustrated ratchet-like ladder, theouter adjustment sleeve 116 can be advantageously readjusted.

[0040]FIGS. 2B and 2C illustrate example structures for the pin holder130 and the pin 114. The pin holder 130 includes an aperture 130 a forsecuring therein the pin 114 of FIG. 2C. The cam-like surface of the pinholder 130 is depicted as 130b. The pin 114 of FIG. 2C is expanded toshow the bulb surface 114a for engaging and expanding the end 118 c ofthe lock 118 (FIG. 2E), the tip 114 b for incising the body wall, andthe shaft 114 c that enters the port 112 b of the main body 112 (FIG.2A).

[0041] The lock 118 of FIG. 2E and the outer adjustment sleeve 116 ofFIG. 2D further show one of the interlocking sleeve/lock mechanisms. Thelock 118 includes a pliable or flexible end with partially separablemembers 118 c that, in response to receiving the bulb portion 114 a ofthe pin 114 (FIG. 2C), are forced outwardly to mate protrusions 118 dinto apertures 116 a of the sleeve 116.

[0042] These various components of FIGS. 2A-2F can be manufactured in anumber of different ways including, for instance, via molded plastics(e.g., propylene).

[0043] Referring now to FIG. 3A, an alternative surgical instrument 301consists of an elongated rigid tube 302 in which a flexible tube orsleeve 303 is placed within a hollow channel located within the rigidtube 302. The flexible tube or sleeve 303 is supported on the rigid tube302 using a weld 305 attaching the bottom of the tube to the side wall.The flexible tube is also supported with some overlap 306 at the pointat which the rigid tube 302 mates with an entrance receptacle 304 as itattaches to the upper end of the rigid tube 302. The receptacle 304 is afunnel shaped device that has a wide opening 308 and a narrow opening307 for mating with the rigid tube 302. This funnel structure is usefulin guiding the insertion of external instruments into the rigid tube 302and flexible tube 303 by permitting the funnel structure to guide theinstruments towards the center of the rigid and flexible tubes.

[0044] In one embodiment, the flexible tube 303 is constructed of aslippery polyurethane or Teflon-like material to permit the easy passageof an external instrument through the sleeve to exit the rigid tube 302at its first end 306. The flexible tube 303 has a slippery, plastic,polyurethane-like material to provide the required elasticity thatallows the flexible tube 303 to be compressed under pressure and toclose the opening of the inner channel formed within the flexible tube303.

[0045] When in use for laparoscopic surgery, the rigid tube 302 isinserted within a small hole within the body cavity. The small holewithin the body cavity can be sized to match the outer diameter of therigid tube 302. The body cavity is generally pressurized using an inertgas, such as CO₂, such that the internal pressure within the body cavityis greater than the outside air. As such, when the rigid tube 302 isinserted within the pressurized body cavity, this pressurization entersthe rigid tube at its first end 306 compressing the flexible tube 303upwards. Because the flexible tube is attached using along the weld 305,the flexible tube gathers and compresses, closing the opening of theinner channel thus preventing the escape of the pressurized gas frominside the body cavity.

[0046] When in this configuration, a surgical instrument can be insertedthrough receptacle 304, as it is passed through the opening 308 ofreceptacle 304 and to enter within the inner channel of the nowcollapsed flexible tube 303. As the instrument is inserted through theflexible tube, the flexible tube will conform around the externalinstrument, thus permitting the instrument to pass through both theflexible tube 303 and exit the rigid tube 302. At the same time, thepressurization is present within the rigid tube's first end 306. Thepressurization continues to press the flexible tube against the surfacesof the external instrument as it passes through the inner channel, thusmaintaining a within the inner channel. The external instrument can nowbe used to perform surgical procedures within the body cavity.

[0047] As the external instrument is removed, it passes back through theinner channel of the flexible tube. Pressurization from within the bodycavity maintains the collapsed structure of the flexible tube, thusmaintaining the seal of the inner channel around the instrument until itis closed when the instrument is completely removed.

[0048] Referring to FIG. 3B, an end view of the surgical instrumentlooking down towards the top of the receptacle is shown. The outer edge308 shows the outer dimension of the receptacle which funnels downtowards the mating surface between the receptacle and the rigid tube302. The flexible tube 303 is depicted in its closed position as theflexible tube 303 is gathered up to close the opening within the innerchannel formed within 307. While an external instrument is inserted downthrough the center of the structure, the flexible tube 303 conforms tothe shape and surface of the external instrument.

[0049] Referring to FIG. 3C, an embodiment of the present invention isshown in use where a cannula structure 302 is inserted within a bodycavity 301 at an incision 310. A surgical instrument 330 is passedthrough the center of cannula 302 through the inner channel of theflexible tube (not shown in FIG. 3C) that seals the opening through thecannula structure 302. In this particular embodiment, an additionalchannel structure 334 has been added which permits the supply of aninert gas to be placed within the body cavity 301. This structure 334can be an inert gas line that comes from an external source connected toa valve structure 345 and that allows the gas supply to be turned on andoff. In one example embodiment, this valve structure 345 is made part ofthe receptacle housing. This structure 334 is also connected to asecondary tube that runs parallel to the rigid tube 302 of the cannulawith an opening near at the first end of the rigid tube 302 permittingthe gas to enter within the body cavity 301 on the far end side of theflexible tube 303, providing the pressurization within the body cavityneeded to close the inner channel of the flexible tube 303. This supplyof gas can be made part of the canal as described herein or can be madeas a separate structure inserted in the body at some other location.

[0050] The gas supply, as described and illustrated in connection withFIGS. 3A-3C, can be similarly implemented in connection with thestructure shown in FIGS. 1A-1C, with a channel for the gas runninginside or outside the tools main wall.

[0051] The above specification, examples and data provide a completedescription of the manufacture and use of the composition of theinvention. Since many embodiments of the invention can be made withoutdeparting from the spirit and scope of the invention, the inventionresides in the claims hereinafter appended.

I claim:
 1. An apparatus for inserting through a body layer including: an elongated member, and a flexible sleeve where the sleeve is attached to the bottom of the elongated member at an area less than the majority of the periphery of the member so to close an opening through the sleeve when pressure from a body cavity enters the elongated member.
 2. An apparatus, according to claim 1 , wherein the flexible sleeve is constructed and arranged to permit an external instrument to pass through the channel while maintaining the channel closed due to pressurization between the sleeve and an inner surface of the tube.
 3. An apparatus, according to claim 2 , wherein the flexible sleeve has a first end supported near the entry port.
 4. An apparatus, according to claim 3 , further including a flexible sleeve lock that is constructed and arranged to provide another entry port that is aligned with the first-indicated entry port and to secure the first end of the flexible sleeve.
 5. An apparatus, according to claim 4 , wherein the first end of the flexible sleeve is secured adjacent the extended portion of the elongated tube.
 6. An apparatus, according to claim 5 , further including a gas supply channel running along the elongated member and arranged to provide a path outside of the flexible sleeve that passes an externally-supplied gas to the body cavity.
 7. An apparatus, according to claim 6 , wherein the extended portion includes a portion of the gas supply channel.
 8. An apparatus, according to claim 1 , further including an elongated pin constructed and arranged to lock within the elongated member and to puncture or pierce the body layer.
 9. An apparatus, according to claim 8 , wherein the elongated pin is constructed and arranged along with the elongated member to extend adjustably along the elongated tube.
 10. An apparatus, according to claim 8 , further including a sleeve arranged to receive the elongated member and to adjust the extent to which the elongated pin extends from the elongated tube. 